Trials4patients Richmond Pharmacology volunteer recruitment

The safest possible cure

We recently featured the article ‘Chance for a Cure’ (issue date 14/10/2004) describing the pivotal role clinical trials play in the development of crucial new medicines. As a result of the level of interest expressed in the safety aspect of clinical trials Dr. Jörg Täubel of Richmond Pharmacology explained the extensive safety measures that are taken before every clinical trial commences.

Clinical Trials are an essential part of the development of new medicines. Pivotal to these studies is the participation of healthy volunteers and patients, and their safety is the priority of any clinical trial. To ensure that all Researchers maintain the highest possible safety standards, the European Union issued the EU Clinical Trials Directive (2001/20/EC) on May 1st 2004. The principle aim of the Directive is the protection of healthy volunteers and patients. The two governmental bodies that ensure the directive is adhered to are:

  • The Medicines and Healthcare products Regulatory Agency (MHRA)
  • Approved Ethics Committees

The primary role of the MHRA is to ensure the safety of the trial participants. This is achieved through an examination of laboratory and clinical data, resulting in a thorough safety review of the medicine:

“These regulations help to ensure that the rights, safety and well-being of clinical trial subjects are protected by requiring sponsors of trials to be responsible for designing, conducting, recording and reporting clinical trials according to internationally recognised principles of Good Clinical Practice (GCP).” — www.mhra.gov.uk

Every stage of the medicine's manufacture is closely monitored, including the component parts of the medicine. The MHRA then consider how the researchers plan to conduct the study, and assesses every safety aspect related to this. As a final precaution, the approved medicine can only be released for a clinical study by a Qualified Person (QP). The QP is experienced and trained within the field of pharmacy and clinical trials, and has a strong knowledge and understanding of the relevant drug.

The second organisation responsible for the adherence to the Directive is the Ethics Committee. The Ethics Committee's main roles are to consider the safety of the trial from the volunteer's perspective, and to establish whether the trial will produce a worthwhile result that enhances the treatment of future patients, or benefit further research. The committee will only approve a clinical trial if they are satisfied that the volunteers' best interests are being considered.

Facilities at Richmond PharmacologyThe Committee examine every component of the trial that affects the volunteers, to ensure they are fully informed of the trial and enable them to make a decision about participation. The trial facilities are inspected to ensure they are safe and comfortable. All written information made available to the volunteer is reviewed for its accuracy and clarity, and all volunteer information is treated confidentially. Any advertising related to the trial is reviewed to make sure its contents are ethical. Like the MHRA, the Ethics Committee carries out a safety review how the researchers plan to conduct the study.

NHS Research Ethics Committees (RECs) have been established throughout the UK for many years with the purpose of safeguarding the rights, dignity and welfare of people participating in research […] The REC is entirely independent of the researcher and the organizations funding and hosting the research […] There are currently about 200 RECs in the UK.” — www.corec.org.uk

The MHRA and the Ethics Committee work independently of the CRO. This guarantees an objective and unbiased review of the proposed trial to ensure the safety of the volunteers is the priority. Only upon approval of both these government bodies can any clinical trial commence.

The UK is at the forefront of the European implementation of the EU Clinical Trials Directive (2001/20/EC).

Dr Jörg Täubel “Richmond Pharmacology fully supports the EU Directive and the positive effects this has on healthy volunteers and patients, and we are committed to this principle. Further to the regulations that all researchers must adhere to, if appropriate we seek the advice of external experts who have specialist knowledge in particular medicines and how to conduct studies. By taking this extra precaution we are confident that the trials we run are conducted in the safest possible environment.” commented Dr Täubel.

Richmond Pharmacology conduct clinical trials including healthy volunteers and patients to give sick people chance for a cure. Clinical trials are an essential and regulated part of developing new medicines and therapies. One area of clinical research is Bridging Studies: these types of studies are designed to compare the impact of medicines and therapies on different populations such as Japanese and Caucasians.

If you would like any further information on clinical trials or are interested, Richmond Pharmacology can be contacted on 08000 27 37 47 or visit www.trials4japanese.co.uk or www.trials4us.co.uk.

Originally published in Journey magazine.